Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Amlodipine; Valsartan

Criteria

Inclusion Criteria:

• 18 years of age or older.

• Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.

Exclusion Criteria:

• History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics

• Inability to stop all prior blood pressure medications safely

• Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg

• Controlled blood pressure (systolic BP < 140 mmHg) taking more than 3 antihypertensive medications at screening

• Systolic BP ≥ 140 mmHg and < 180 mmHg taking more than two antihypertensive medications at screening

• Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening

• History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina

• Type 1 diabetes

• Poorly controlled Type 2 diabetes

• History of heart failure

• Arrhythmia

• Significant valvular heart disease

• Active gout

• History of autoimmune diseases

• History of multiple drug allergies

• Liver disease

• Pancreatic injury within 1 year of screening

• Evidence of kidney impairment or history of dialysis

• Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.

• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed

• Pregnant or nursing (lactating) women

• History of malignancy of any organ system within the past five years

• Any severe, life-threatening disease within the past five years

• History of drug or alcohol abuse within the last 2 years.

Other protocol-defined inclusion/exclusion criteria may apply